NCT00217607

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

September 20, 2005

Last Update Submit

August 29, 2016

Conditions

Sarcoma

Keywords

adult angiosarcomarecurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    2 months

Secondary Outcomes (7)

  • Response rate

    4 months

  • Response rate

    6 months

  • Tolerability

    6 months

  • Time to progression

    5 years

  • Overall survival

    5 years

  • +2 more secondary outcomes

Study Arms (1)

Paclitaxel

EXPERIMENTAL

Paclitaxel 80 mg/m² Day 1, Day 8 and Day 15. No treatment on Day 22. 1 cycle = 28 days. Treatment duration: 6 cycles (=6 months)

Drug: paclitaxel

Interventions

paclitaxelDRUG
Paclitaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue angiosarcoma or lymphangiosarcoma * Locally advanced or metastatic disease * Unresectable disease * Angiosarcomas in previously irradiated areas allowed provided disease is clearly progressive * Measurable disease * No Kaposi's sarcoma PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 3 times upper limit of normal (ULN) * SGOT and SGPT \< 2.5 times ULN * No severe liver failure Renal * Creatinine clearance \> 60 mL/min * No severe kidney failure Cardiovascular * LVEF ≥ 50% Other * Not pregnant or nursing * Fertile patients must use effective contraception * No weight loss ≥ 20% of body weight prior to illness * Patient must be amenable to receiving care during the day * No HIV positivity * No clinical neuropathy * No known allergy to study drug or to any of its components (e.g., Cremophor EL) * No other progressive malignant tumor * No chronic illness (somatic or psychiatric) that would preclude study compliance and follow-up * No psychological, geographical, or social reason that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 2 prior courses of chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified Other * No other concurrent anticancer therapy * No concurrent participation in another therapeutic investigational study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Cochin

Paris, 75674, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (1)

  • Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22.

    PMID: 18809609RESULT

MeSH Terms

Conditions

SarcomaHemangiosarcoma

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Nicolas Penel, MD

    Centre Oscar Lambret

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

February 1, 2005

Primary Completion

April 1, 2008

Study Completion

January 1, 2012

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared at an individual level.

Locations

FR(23)